Coagulation Factor Inhibitor Plasmas (FIPs) are produced from normal human plasmas from which specific factors have been removed by selective affinity immuno-adsorption and an antibody inhibitory to the specific factor is added to provide neutralizing activity. These products can be used as a substitute for plasmas from patients that have developed neutralizing antibodies to coagulation factors. All of these products are intended for research use only.
Normal citrated human plasma depleted of Factor VIII using antibodies directed to FVIII complex immobilized on agarose beads. A polyclonal antibody inhibitory to FVIII has been added to provide FVIII neutralizing activity.
Advantages:Availability: FIPs are an economical and reliable alternative to human clinical source material that can be very difficult to obtain. Even samples form extremely rare conditions can be emulated in this way. FIPs are available in volumes ranging from 1ml vials up to bulk volumes.
Consistency:Using antibodies of known neutralizing activity and factor-deficient plasma, much greater control of potency between lots is achieved.
Safety:FIPs are made from normal plasma tested at source and found negative for HBsAg, RPR and antibodies fot HCV, HIV. Non-reactive for HIV-1 rNA and HCV rNA by FDA approved tests. Should be handled by personnel trained in the proper procedures for handling potential viral contaminants.
Specifications:PT (Stago Neoplastine C1+): As reportedAPTT (HemosIL APTT-SP):As reportedFibrinogen (clottable): As reportedFVIII (activity): As reportedFVIII Inhibitor activity (Bethesda assay)*: As reported
Note:Bethesda assay performed at at 1:5 dilution, then mixed with an equal volume of normal plasma and incubated at 37ºC for 120 min. The FVIII activity was measured by one stage clotting assay and the residual FVIII activity is converted to Bethesda units using the Bethesda chart or graph. The Bethesda value derived (BU/ml) is multiplied by the initial dilution of the sample to obtain the corrected inhibitor concentration.
Custom Specifications:For special applications, FIPs can be produced to specific potencies in any volume range. Please inquire.
Storage and Stability:For long-term storage, aliquot to avoid repeated freezing and thawing and freeze at -70°C. For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap. Aliquots are stable for 6 months.
